Functional formulation

ABSTRACT

Nutraceutical gum or functional food compositions comprise Ashwagandha ( Withania somnifera ) and L-theanine in a sublingual formulation. Methods of making suitable sublingual formulations are described. Also provided is a method for reduction of stress and/or enhancement of energy and mental clarity, comprising administering to an individual in need thereof an effective amount of a nutritional composition comprising Ashwagandha herb and L-theanine, and a nutraceutically acceptable carrier, wherein the nutritional composition is administered sublingually.

This application is a Divisional of U.S. application Ser. No.13/296,034, filed Nov. 14, 2011, which claims the benefit of earlierfiled U.S. Provisional Application No. 61/381,910, filed on Nov. 16,2010, each of which are hereby incorporated by reference herein.

FIELD OF THE INVENTION

A nutraceutical gum or functional food composition comprises Ashwagandha(Withania somnifera) and L-theanine. Embodiments of the formulationinclude ingredients balanced in a synergistic manner to elicitcomplementary effects which provide reduction of stress and alleviationof fatigue, enhancement of energy and a boost in mental clarity andconcentration. Methods of making suitable sublingual formulations aredescribed.

BACKGROUND

In countries where traditional medicine is practiced, particularly inthe East, it has been estimated that up to 80% of the populationcontinues to use these traditional methods to treat primary medicalproblems. In the past decade or so, research has been increasinglyfocused on scientific evaluation of traditional medicines and drugs ofplant and herbal origin, including methods derived from indigenous ortribal populations.

One such herb is Ashwagandha (Withania somnifera), so named in Sanskritdenoting its rejuvenative or vital properties (ashwa: horse; gandha:smell), which is said to confer the strength and vitality of a horse.This herb has long been used in the Ayurvedic formulary of India.Ashwagandha is commonly referred to as “Indian Ginseng” because of itsbeneficial properties. See, M. S. Premila, Ayurvedic Herbs: A ClinicalGuide to the Healing Plants of Traditional Indian Medicine (2007, TheHaworth Press, New York).

Herbalists have identified Ashwagandha as an adaptogen. The term“adaptogen” is used herein to refer to natural herb products which arebelieved to increase the body's resistance to stress, trauma, anxietyand fatigue. In the past, adaptogens have been called rejuvenatingherbs, restoratives, qi (i.e. “chi”) tonics, or rasayanas. While notintending to be bound by theory, it has been proposed that adaptogenicherbs have a “normalizing effect” on the body and may be capable ofeither toning down the activity of hyperfunctioning body systems, orstrengthening the activity of hypofunctioning body systems. For example,it has been proposed that adaptogenic herbs have the ability to balanceendocrine system hormones and the immune system, and thus help the bodyto maintain homeostasis.

Other well known herbal adaptogens include licorice, ginseng, Reishi,and Astragalus. These useful herbs have been often studied in recentyears as components in nutraceuticals, dietary supplements, and asdietary ingredients in functional foods.

Another compound associated with relaxation and reduction of stress isL-theanine (N-ethyl-L-glutamine), which is a component found in bothgreen and black tea. Tea is the only significant dietary source ofL-theanine, and it has been proposed that L-theanine can induce arelaxed state. As an amino acid derivative, L-theanine rapidly crossesthe blood-brain-barrier and thereby acts directly on the brain.L-theanine has been studied in combination with caffeine, which revealssynergistic effects in cognition and mood (C. F. Haskell, et al., Biol.Psychol. (2008) 77: 113-122).

The adaptogenic properties of Ashwagandha herb would appear tocomplement the anti-stress property of L-theanine. If Ashwagandha herband L-theanine were combined, the resulting nutraceutical would providea useful contribution to the art.

In view of the above, there is a need and a desire for a dietarysupplement and/or functional food including Ashwagandha herb andL-theanine in combination, that exploits the potential beneficialproperties of both components in a readily bioavailable formulation.

SUMMARY OF THE INVENTION

In one embodiment, the invention relates to a nutritional gumcomposition comprising Ashwangandha herb and L-theanine in combinationwith a nutraceutically acceptable carrier.

In another embodiment, a method for making a nutritional gum compositioncomprising Ashwangandha herb and L-theanine is provided.

Also provided is a method for reduction of stress and/or enhancement ofenergy and mental clarity, comprising administering to an individual inneed thereof an effective amount of a nutritional composition comprisingAshwagandha herb and L-theanine, and a nutraceutically acceptablecarrier, wherein the nutritional composition is administeredsublingually.

DETAILED DESCRIPTION

A nutritional composition comprising a complementary combination ofAshwagandha herb and L-theanine has been discovered. Use of the twocomponents singularly does not produce the desired effects of stressreduction and enhancement of energy and/or mental clarity, nor does oraldelivery through traditional pill form, nor by ingestion or in abeverage, of the two components either singularly or in combination aspart of functional foods absorbed in the intestine. The advantageouseffects are achieved only by combining the two ingredients in a rapidlyabsorbed sublingual or buccal formulation, or through some otherequivalent delivery system that is rapidly absorbed by the oral or nasalmucosa. One useful sublingual, functional food delivery system includeschewing gums or confectionaries. Other sublingual delivery systemsinclude, but are not limited to, dissolvable tabs placed under and/or onthe tongue, liquid drops, beverages, oral dissolvable films or oraldissolvable strip technology. These techniques include edible films andeffervescent-edible substances.

Sublingual use of the combination of Ashwagandha herb and L-theanineprovides rapid delivery of the active ingredients to the bloodstream andrapid onset of beneficial effects to the user, including relaxation,stress reduction, and satiety, among others. The ease of use and speedof onset through sublingual delivery provides value to the user and anunexpected synergistic effect. As defined herein, the term “stress” isgenerally defined as an absence or lack of relaxation, or the presenceof anxiety, and/or the loss of a general sense of well-being in anindividual or human patient.

Because Ashwagandha herb and L-theanine produce different butcomplementary effects on the human body and its systems, varying theratio of the two ingredients has been found to advantageously change theeffects experienced by human subjects. Amounts of the two ingredientsAshwagandha herb and L-theanine in the embodiments of the invention willvary according to the effect desired.

Ashwagandha herb can be provided, for example, in Ashwagandha rootextract powder, standardized to greater than 5% withanolides by weight.Ashwagandha root extract can be obtained containing negligible amountsof withaferin A (less than 0.1%), however, in other embodimentswithaferin A can be contained in Ashwagandha herb or added to theformulation. Suitable Ashwagandha extract is available, for example,from Nutragenesis (Brattleboro, Vt.). Useful ranges of Ashwagandha herbcan be from about 10 mg to about 250 mg, or preferably from about 70 mgto about 150 mg, in combination with an effective amount of L-theanine.One suitable range of Ashwagandha herb is from about 70 mg to about 110mg, in combination with an effective amount of L-theanine. The ranges ofbioactive components are generally expressed per serving. A useful dosecan include one or more servings.

Useful ranges for L-theanine (for example, available from Purebulk,Pharhome International Limited, Guangdong, China) can be from about 20mg to about 200 mg, or preferably from about 50 mg to about 125 mg, incombination with an effective amount of Ashwagandha herb. One suitablerange of L-theanine is from about 80 mg to about 120 mg, in combinationwith an effective amount of Ashwagandha herb. The ranges of bioactivecomponents are generally expressed per serving. A useful dose caninclude one or more servings. For example, a useful dose is about 200 mgof L-theanine and about 160 mg of Ashwagandha, which can be provided inone or more servings, for example, in a gum piece. In another example,two servings of a single gum piece including about 100 mg of L-theanineand about 80 mg of Ashwagandha would provide the aforementioned dose. Inone embodiment, a finished gum piece containing useful and effectiveamounts of both L-theanine and Ashwagandha can range in weight fromabout 1700 mg to about 2300 mg. In another embodiment, the finished gumpiece containing useful and effective amounts of both L-theanine andAshwagandha is about 2000 mg.

L-Theanine can be obtained at purity levels of 95%, or higher, which isuseful in embodiments of the present invention. L-Theanine may take theform of a salt, alternatively an internal salt, or an addition salt ofan appropriate acid or base. Suitable acid addition salts may beprepared from an inorganic acid or from an organic acid. Examples ofinorganic acids include hydrochloric, hydrobromic, sulfuric, phosphoric,and the like, or combinations thereof. Examples of organic acids includeacetic, succinic, gluconic, lactic, malic, tartaric, citric, ascorbic,maleic, fumaric, pyruvic, aspartic, glutamic, benzoic, trifluoroacetic,stearic, and the like, or combinations thereof. Suitable base additionssalts include, for example, metallic salts including alkali metal,alkaline earth metal and/or transition metal salts, such as, forexample, calcium, magnesium, potassium, sodium, lithium, and zinc salts.Pharmaceutically acceptable base addition salts also include organicsalts made from basic amines, such as, for example,N,N′-dibenzylethylenediamine, chloroprocaine, choline, diethanolamine,ethylenediamine, meglumine (N-methylglucamine), tromethamine(tris(hydroxymethyl)aminomethane), and procaine.

Because Ashwagandha and L-theanine produce different but complementaryeffects in the human body, varying the ratio of the two ingredientschanges the effect experienced by the body. With that in mind, amountsfor the two ingredients in any particular embodiment of the inventionwill vary according to the effect desired. Taking into consideration thecomponent ranges described above, when greater relaxation is desired,the ratio of Ashwagandha to L-theanine will be higher. When greaterreduction of stress or mental clarity is required, the ratio ofL-theanine to Ashwagandha will be higher.

In an embodiment, an effective sublingual formulation comprises a gum, aconfection, or a dissolvable tab/tablet. One formulation comprises achewing gum having Ashwagandha extract in an amount from about 70 mg toabout 110 mg, in combination with L-theanine in an amount from about 80mg to about 120 mg, and a nutraceutical carrier. Optionally, the chewinggum can include bergamot, chamomile, and/or lavender extracts.Optionally sweeteners can be added including, but not limited to xylitol(Chemaster International Inc., Qingdao, China), sorbitol (Pure Chem,Ltd., Bangkok, Thailand), isomalt (Chemaster International Inc.,Qingdao, China), maltitol (Pure Chem, Ltd., Bangkok, Thailand), Steviaor Stevia extract (90% by weight available from Shaanxi Run-timeBio-technology Development Co., Ltd, Shaanxi, China), and the like, orcombinations thereof. Useful excipients and fillers in said formulationsinclude gumbase, gum arabic, magnesium stearate (Hangzhou RuijiangChemical Co., Ltd., Zhejiang, China), calcium stearate, carnauba wax(ChemCor, Chester, N.Y.), titanium dioxide (Shanghai Weiyi IndustrialCo., Ltd., Shanghai, China), silicon dioxide (Hangzhou Ruijiang ChemicalCo., Ltd., Zhejiang, China), modified food starch (Angel Starch &Chemicals Pvt Ltd, Tamil Nadu, India), and the like, or combinationsthereof. Useful powdered gumbases include CPG from Gum Base Co. (Milan,Italy). Another suitable gumbase is available from Gumlink (Vejle,Denmark). Natural flavors and/or flavorants can include, but are notlimited to, natural vanilla, sweet peppermint, menthol, menthol powder,and the like, or combinations thereof. Artificial flavors can be used.Suitable natural and artificial flavors are available from FlowerFlavours & Fragrances Co., Ltd., (Guangdong, China). Natural colors caninclude, but are not limited to, titanium dioxide white. Coatings, forexample, pharmaceutical glaze or confectioner's glaze (AustradeIncorporated, Palm Beach Gardens, Fla.), can be used.

The gum embodiment can be designed to maximize sensations of relaxationand satiety, among other effects. For example, other primary effects ofAshwagandha (Withania somnifera) and L-theanine can include: (1)reduction of stress, i.e. general relaxation: specifically by helping toincrease resistance to fatigue, stress, and tension, by assisting thebody to cope with stress, and by promoting a feeling of well-being; (2)energy: specifically by enhancing energy levels while helping toalleviate or reduce fatigue, by restoring and sustaining energy levels,building and/or boosting energy, and building physical stamina; (3)mental cognition: specifically by helping to alleviate mental fatigue,helping to sharpen focus and mental stamina, and boosting mental clarityand concentration; (4) weight management: specifically by helping tocontrol stress-related eating, inhibiting and controlling stress-relatedovereating, and managing stress-induced appetite; (5) glucose release,specifically by helping to balance blood sugar levels; (6) immunesupport: specifically by promoting healthy immune function, bysupporting cellular defenses, e.g., immunomodulation, by supporting thebody's immune defenses, and by enhancing macrophage production; (7)adaptogenic: specifically by helping to regulate and balance healthymetabolic function, enhancing energy levels while helping to alleviatefatigue (as discussed above), by providing adapation to stress, andnormalizing effects; and (8) anti-aging: specifically by helping to slowthe effects of aging by inhibiting oxidative damage to cells andtissues, by attenuating the effects of pro-oxidative cellular damage,and by protecting against free radical damage to cells.

Components in the Gum Formulation

Ashwagandha (Withania somnifera) is an erect shrub found growing wildthroughout the hotter parts of India and is cultivated for its roots,which are well known in Ayurveda for their rejuvenative or rasayanaproperties. The roots contain 0.2-0.3% of alkaloids and withaferin Atogether with several withanolides, which are C-28 steroidal lactones ofthe ergostane type. In addition, the roots contain starch, reducingsugars, hentriacontane (C₃₁-normal alkane), and a number of amino acids.Also present are sitoindosides VII and VIII, which are acylsterylglucosides, and sitoindosides IX and X, which are C-28 glycowithanolidesthat may contribute to the adaptogenic properties found in this herb.There are several chemotypes of the plant Ashwagandha (Withaniasomnifera) available with varying amounts of the various sitoindosides.See, M. S. Premila (2007), Ayurvedic Herbs, and references citedtherein.

Ashwagandha (Withania somnifera) root powder, root methanol extract, andits active principles (a mixture containing equimolar concentrations ofwithaferin A and sitoindosides VII-X), have been shown to possessantioxidant activity, which may explain the antistress,anti-inflammatory, immunomodulatory, and cognition-enhancing andrejuvenative effects shown in experimental and clinical studies.Withaferin A has been shown to have anti-inflammatory and antiarthriticproperties in several experimental models. See, M. S. Premila (2007),Ayurvedic Herbs, and references cited therein.

With respect to CNS activity, defined extracts of Ashwagandha (Withaniasomnifera) consisting of mixtures of sitoindosides VII-X and withaferinA prepared by combination of equimolar amounts of the compounds takenfrom Withania somnifera induced an increase in the cortical muscarinicacetylcholine capacity, which may partly explain the cognition-enhancingeffects seen both in animals and humans (Neurochem. Int. (1997)30:181-190).

In human clinical trials for arthritis, use of up to 6 g of Ashwagandha(Withania somnifera) root powder for 3-4 weeks was well tolerated(Indian J. Med. Res. (1968) 56:1581-1583). In a long-term trial onhealthy volunteers in the age group of 50-59 years to study its tonicantiaging effect, 3 g of the root powder in three divided doses for oneyear showed no untoward side effects (J. Res. Ayur Siddha (1980)1:247-258).

In animal models, acute toxicity and a 4-week subacute study withaqueous extract of Ashwagandha (Withania somnifera) in doses from 50mg/kg to 1 g/kg showed no toxic effects, and no hepatic or renaltoxicity (Phytother. Res. (1999) 13:275-291). Also, chronic feeding ofAshwagandha at 100 mg/kg for 180 days did not show any toxicity orsignificant changes in the biochemical profile of blood (J.Ethnopharmacology (2000) 70:57-63).

L-Theanine has been found primarily in green and black tea species.L-Theanine (N-ethyl-L-glutamine) is an amino acid derivative found inspecies of Camellia and in the edible bay boletes mushroom Xerocomusbadius, but is otherwise rare in nature. It is the major amino acid intea and is thought to be a flavorous constituent of tea leaves.L-Theanine constitutes between 1% and 2% of the dry weight of tea whichcorresponds to about 25 mg to about 60 mg per 200 mL serving.

L-Theanine readily crosses the blood-brain barrier in a dose-dependentmanner to exert its effects directly on the brain within about 30minutes. L-Theanine can reach maximal levels 5 hours after ingestion inanimals, and it is thought to influence the central nervous system (CNS)through a variety of mechanisms, including effects on neurotransmitters(J. Bryan, Nutrition Reviews (2007) 66:82-90). L-Theanine significantlymodulates the resting state of brain activity. After administration ofL-theanine, increases in alpha band activity supports a role for thisagent in achieving a relaxed, but alert mental state via a directinfluence on the CNS (Nobre, et al., Asia Pac. J. Clin Nutr. (2008)17:167-168). Furthermore, L-theanine can induce a mild, relaxing effectwhen consumed in foods and beverages.

After ingesting Ashwagandha and L-theanine as supplements or part offunctional foods, it requires that the extracts spend an hour or longerin the stomach before passing into the small intestine where absorptionbegins—at which point, it will take an additional 2-3 hours for theherbs to fully cross the intestinal wall and make their way into thebloodstream. The herbs will have an effect, but the effect is spread outover so much time that the effect will not be readily noticed undernormal circumstances by the user.

On the other hand, by providing a sublingual delivery system that keepsthe extracts in maximum contact with the blood vessel rich tissues ofthe mouth for the longest possible time, large amounts of the activecomponents make their way directly into the bloodstream through themouth in a matter of 30-120 seconds and from there go directly into thebrain. Consequently, the desired effects (relaxation, satiety, smoothenergy, mental clarity, etc.) are experienced strongly and almostimmediately.

Also contemplated in certain embodiments is the addition of othersuitable and advantageous and/or complementary herbs, herbal extracts,and nutraceuticals. The addition of other herbal extracts andnutraceuticals can help to push the effects further in any desireddirection. For example, the addition of herbs such as bergamot,lavender, and/or chamomile to the invention will push a givenformulation embodiment more towards relaxation. The addition of bacopaand/or green tea (including caffeine) will produce a non-jittery energyin the formulation embodiment. The addition of gingko biloba willincrease blood flow to the brain and augment the mental clarity aspectsof the formulation embodiment.

Additional Components

Gotu Kola Leaf has been referred to as “food for the brain.” ThisAyurvedic herb has demonstrated the ability to improve mental functionssuch as concentration and memory. It has a calming effect on the bodyand is chiefly used to support the central nervous system. In effect,regular use of Gotu kola can rebuild mental energy reserves. Gotu kolacan be helpful in dealing with attention deficit disorder (ADD), sinceit increases the ability to focus while having an overall soothing andrelaxing effect on the nervous system.

Calamus Root is traditionally used for its ability to “stimulate” themind and evoke a cheerful mood. Years ago, Canadian trappers regularlychewed it as a stimulant whenever tired—a trick they learned from theCree Indians, who used calamus to fight the effects of exhaustion orfatigue, and to help treat or prevent hangovers.

Rosemary Leaf is a valuable circulatory stimulant, with a particularaffinity for cerebral circulation. It is a stimulating tonic herb usefulfor those suffering from depression or nervous exhaustion—and isextremely helpful in improving memory and concentration. In fact, thatis why Rosemary is traditionally let at gravesides and handed to thebereaved—for remembrance.

Kola Nut contains 1.5-2% caffeine, plus theobromine (an alkaloid similarto caffeine) that increases cerebral circulation. Kola is believed topromote better concentration and a “clearing” of the head. When limitedamounts of Kola nut are consumed in a formulation, and because itsactives go straight to the brain, its stimulatory effect is limited tothe brain and has very little impact on the adrenals, unlike coffee.

Cayenne is used as a catalyst in many herbal formulas. It may help todrive the other herbs into the bloodstream. In an embodiment, when usedin a tincture that is taken sublingually, it can help to acceleratetransport of active components of the other herbs directly into thebrain, which is one of the reasons this formula is so effective.

Periwinkle is used as a cerebral vasodilator for enhancing mentalalertness. It increases blood flow to the brain and improves itsoxygenation. Vinpocetine, from the extract of the periwinkle plant, hasover 100 clinical trials proving that periwinkle improves cerebralmetabolism, increases cerebral blood flow, increases use of glucose andoxygen in the brain, increases serotonin levels, etc.

Any of the additional components can optionally be used in a nutritionalformulation having a combination of Ashwagandha herb and L-theanine. Thenutritional formulations described herein can be included innutraceutical products and functional foods. Preferred nutritionalformulations described herein comprise sublingual and buccalpreparations.

Delivery System

The use of sublingual delivery in the invention makes a vital differencein the end product. Normal ingestion of functional foods takes severalhours for complete release of the bioactive components, as they mustmake their way from the stomach into the small intestine, whereabsorption takes place—again over several hours. This means the impactof the actives is spread out over several hours.

Sublingual use of the combination of Ashwagandha herb and L-theanineprovides rapid delivery of the active ingredients to the bloodstream andrapid onset of beneficial effects to the user, including relaxation,stress reduction, and enhancement of energy with mental clarity, amongothers. The ease of use and speed of onset through sublingual deliveryprovides value to the user and an unexpected synergistic effect.Suitable methods of administration include, but are not limited to,sublingual, buccal, oral, intranasal, inhalational, and the like.

Suitable dosage forms include tablets, capsules, solutions, suspensions,powders, gums, and confectionaries. Other sublingual delivery systemsinclude, but are not limited to, dissolvable tabs under and on thetongue, liquid drops, and beverages. Edible films, hydrophilic polymers,oral dissolvable films or oral dissolvable strips can be used. Otheruseful delivery systems comprise oral or nasal sprays or inhalers, andthe like. Beverage embodiments are contemplated with flavor enhancementsand/or various flavors added, as appropriate.

The nutritional compositions are preferably in unit dosage forms. Insuch form, the preparation is subdivided into unit doses containingappropriate quantities of the active component(s). The unit dosage formcan be a packaged preparation, the package containing discretequantities of preparation, such as packaged gum pieces, tablets,capsules, and powders in vials or ampoules. Also, the unit dosage formcan be a gum piece, capsule, tablet, cachet, or lozenge itself, or itcan be the appropriate number of any of these in packaged form.

Gum formulations are preferred. In one embodiment, the nutritionalcomposition may be in the form of a gum product.

In accordance with other embodiments, carbonated beverage versions thatuse the same herbal/nutraceutical formulations as their gum counterpartscan be used. Although, not offering the same contact time in the mouthas a gum delivery system, the light carbonation is believed to push theactives into the blood vessels of the mouth more quickly, thus providinga virtually identical sublingual effect—but in a form acceptable tothose who do not wish to chew gum. Carbonated beverage embodiments arecontemplated with flavor enhancements and/or various flavors added, asappropriate.

For oral administration, the bioactive components may be combined withone or more solid inactive ingredients for the preparation of gumpieces, tablets, capsules, pills, powders, granules or other suitabledosage forms. For example, the active agent may be combined with atleast one excipient such as fillers, binders, humectants, disintegratingagents, solution retarders, absorption accelerators, wetting agents,absorbents, or lubricating agents. Other useful excipients includemagnesium stearate, calcium stearate, mannitol, xylitol, sweeteners,starch, carboxymethylcellulose, microcrystalline cellulose, silica,gelatin, silicon dioxide, and the like.

The nutraceutical compositions of the present invention may beadministered in combination with a nutraceutically acceptable carrier.The active ingredients in such formulations may comprise from 1% byweight to 99% by weight, or alternatively, 0.1% by weight to 99.9% byweight. “Nutraceutically acceptable carrier” means any carrier, diluentor excipient that is compatible with the other ingredients of theformulation and not deleterious to the user.

In accordance with one embodiment, a method for reduction of stress isprovided, comprising administering to an individual in need thereof anutraceutically effective amount of a combination of Ashwagandha herband L-theanine. The combination of Ashwagandha herb and L-theanine is anutritional composition or functional food in combination with anutraceutically acceptable carrier.

In accordance with another embodiment, a method for enhancing energyand/or increasing mental clarity is provided, comprising administeringto an individual in need thereof a nutraceutically effective amount of acombination of Ashwagandha herb and L-theanine. The combination ofAshwagandha herb and L-theanine is a nutritional composition orfunctional food in combination with a nutraceutically acceptablecarrier.

Solid nutritional compositions for oral administration in connectionwith a method for promoting reduction of stress and enhancing energy mayoptionally contain, in addition to the above enumerated nutritionalcomposition ingredients or compounds: carrier materials such as cornstarch, gelatin, acacia, microcrystalline cellulose, kaolin, dicalciumphosphate, calcium carbonate, sodium chloride, alginic acid, and thelike; disintegrators including, microcrystalline cellulose, alginicacid, and the like; binders including acacia, methylcellulose, sodiumcarboxymethylcellulose, polyvinylpyrrolidone, hydroxypropylmethylcellulose, ethyl cellulose, and the like; and lubricants or flowagents such as magnesium stearate, calcium stearate, stearic acid,silicone fluid, talc, waxes, oils, colloidal silica, and the like. Theusefulness of such excipients is well known in the art.

Liquid nutritional compositions for oral administration in connectionwith a method for promoting reduction of stress and enhancing energy canbe prepared in water or other aqueous vehicles. In addition to the aboveenumerated ingredients or compounds, liquid nutritional compositions caninclude suspending agents such as, for example, methylcellulose,alginates, tragacanth, pectin, kelgin, carrageenan, acacia,polyvinylpyrrolidone, polyvinyl alcohol, and the like. The liquidnutritional compositions can be in the form of a solution, emulsion,syrup, gel, or elixir including or containing, together with the aboveenumerated ingredients or compounds, wetting agents, sweeteners, andcoloring and flavoring agents. Various liquid and powder nutritionalcompositions can be prepared by conventional methods.

In one embodiment, the nutritional composition will be in the form of agum. A gum formula allows for release of the active components intosaliva, which maximizes their contact time with the blood vessels insidethe mouth. The actual process used in manufacturing the gum is designedto optimize this effect even further.

In accordance with one embodiment, a method of making a nutritional gumcomposition is provided. A cold compressed gum format is used whichallows for the greatest consistency of functional ingredients in eachpiece of gum. Unlike traditional, extruded gum, cold compressiontechnology uses no heat or moisture during manufacturing. This assuresthat substantially no actives are lost in manufacturing andconsequently, about 100% release of actives during consumption. Thismanufacturing technique enables a work process including very fragileactive ingredients such as probiotics that would not survive aconventional extruded gum manufacturing process.

Controlled temperature and humidity operations are employed, withgenerally no high temperature exposures, in the gum compression andsugar free coating processes so that all of the active ingredientsmaintain their efficacy and potency. This allows for very precise dosageand accurate and consistent delivery of functional ingredients. Inproduction, the powdered active and inactive ingredients are blended,and compressed using a pharmaceutical grade, Fette tablet press (FetteAmerica, Rockaway, N.J.). Optionally, the gumbase can be liquefied at alow temperature thus purifying the gum base. The liquified base can bepoured into a mixer that blends the ingredients. Sweeteners, flavors,and bioactives (optionally, microencapsulated so as not to affect theflavor) are added and then slowly mixed in. The gum mixture is then sentto a press, which stamps out the circular pieces of gum. The gum piecesare then moved to a temperature-controlled environment to cool. Thisensures the finished product will have the right consistency and stayfresh on store shelves.

In an embodiment, after a controlled, low-temperature heat treatment(referred to as “tempering”), the gum pieces are then fed into a spraydrier that forms a crunchy coating around the center. It tumbles thepieces while a prepared syrup mixture, made of filtered water,sweeteners, and coloring, is sprayed onto the gum piece(s). Thiscombination of tumbling and spraying forms a candy shell around the softcenters. The dried shell coating generally covers the gum-based centersof the gum pieces as an exterior layer, and alternatively, substantiallycompletely covers the gum-based centers of the gum pieces. In anembodiment, the coating completely encapsulates the gum-based centers ofthe gum pieces.

In another embodiment, the gum pieces are loaded into conventionalpanning equipment. One or more layers of polyol syrup are applied usinga sprayer or ladle. The rotational motion of the pan facilitates thespreading and subsequent drying of the syrup, forming a crunchy shellthat covers the gum pieces. The dried shell coating generally covers thegum-based centers of the gum pieces as an exterior layer, andalternatively, substantially completely covers the gum-based centers ofthe gum pieces. In an embodiment, the coating completely encapsulatesthe gum-based centers of the gum pieces.

The nutritional composition and methods described above may be furtherunderstood in connection with the following Examples.

EXAMPLE 1A Gum Formulation

A representative serving of nutritional gum may include or consist ofthe following ingredients of Table 1:

TABLE 1 Ingredient Range (mg) Gum base 400-600 Sorbitol 380-440 Xylitol250-310 Isomalt 215-235 Maltitol 190-230 L-Theanine  50-125 Ashwagandhaextract  80-150 Magnesium stearate 50-55 90% Stevia extract  8.0-12.0Silicon dioxide 4.0-5.0 Titanium dioxide 2.0-4.0 Carnauba wax 1.5-2.5Confectioner's glaze 1.5-2.5 modified food starch 2.5-3.5 natural andartificial flavors  90-110 Gum Piece Total 1724.5-2284.5

EXAMPLE 1B Gum Preparation

In accordance with one embodiment, a serving of a nutritional gumcomposition is prepared. The following ingredients are blended:Ashwagandha Root Extract powder (80 mg to 150 mg), L-theanine (50 mg to125 mg), gumbase, sorbitol, isomalt, xylitol, maltitol, magnesiumstearate, natural and artificial flavors, modified food starch, steviaextract, carnauba wax, silicon dioxide, titanium dioxide, and confectionglaze, as follows (on a scale appropriate to produce multiple servings).A powdered gumbase is manufactured by blending different gumbasecompositions with the other ingredients through a series of mixing,drying and milling steps at temperatures ranging between 60° F. and 210°F. (about 15° C. to about 100° C.). The resulting gum powder is sent toa tablet press, which stamps out the circular pieces of gum. The gumpieces are then loaded into conventional panning equipment. One or morelayers of polyol syrup are applied using a sprayer or ladle. In thisembodiment, the polyol syrup can include several sugar alcoholsindicated above including maltitol, xylitol, and isomalt. The rotationalmotion of the pan facilitates the spreading and subsequent drying of thesyrup, forming a crunchy shell that covers the gum pieces. The gumpieces are then held for a minimum of 12 hours before packaging. Eachgum piece comprises one serving.

Optionally, the syrup is made using mainly sugar alcohols and otheringredients for taste and/or color. This would include panning usingmaltitol, xylitol, isomalt or any other “sugar-free” (specifically, freeof sucrose) ingredients. Optionally, other customized flavoring and/orcoloring systems can be used.

EXAMPLE 1C

In one embodiment, the gum ingredients are blended as in Example 1B,using Ashwagandha Root Extract powder (70 mg to about 110 mg) andL-theanine (80 mg to about 120 mg).

EXAMPLE 2 Stress Reduction Method

In accordance with an embodiment, it is expected that an individualhuman subject using the nutritional gum composition of Example 1 bychewing at least one serving, or otherwise consuming in a sublingualfashion, will experience a sensation of relaxation and yet alertnesswithout accompanying drowsiness or sedation. In a variation, it isexpected that an individual will benefit from an anxiolytic effect, bychewing at least one serving of the nutritional gum composition ofExample 1. In a further variation, it is expected that an individualwill experience an enhancement of energy, mental alertness, clarity oracuity and improvement of concentration, by chewing at least one servingof the nutritional gum composition of Example 1.

EXAMPLE 2A Stress Reduction Method

In accordance with the method of Example 2, a serving containing 100 mgL-theanine and 80 mg Ashwagandha Root Extract powder is chewed by ahuman individual. Optionally, within about 10 minutes to 1 hour, asecond serving is chewed by the individual. It is expected that theindividual will experience a sensation of relaxation and yet alertnesswithout accompanying drowsiness or sedation after several minutes, forexample, after about 10 minutes. In a variation, it is expected that anindividual will benefit from an anxiolytic effect, by chewing at leastone serving of the nutritional gum composition after several minutes. Ina further variation, it is expected that an individual will experiencean enhancement of energy, mental alertness, clarity or acuity andimprovement of concentration, by chewing at least one serving of thenutritional gum composition after several minutes.

While in the foregoing specification this invention has been describedin relation to certain embodiments thereof, and many details have beenput forth for the purpose of illustration, it will be apparent to thoseskilled in the art that the invention is susceptible to additionalembodiments and that certain of the details described herein can bevaried considerably without departing from the basic principles of theinvention.

All references cited herein are incorporated by reference in theirentirety. The present invention may be embodied in other specific formswithout departing from the spirit or essential attributes thereof and,accordingly, reference should be made to the appended claims, ratherthan to the foregoing specification, as indicating the scope of theinvention.

I claim:
 1. A sublingual dietary supplement composition comprisingAshwagandha herb and L-theanine in combination with a nutraceuticallyacceptable carrier wherein the composition is selected from the groupconsisting of a lozenge, a capsule, a tablet, a cachet, and aconfection.
 2. The sublingual dietary supplement composition of claim 1which is a lozenge.
 3. The sublingual dietary supplement composition ofclaim 1 which is a tablet.
 4. The sublingual dietary supplementcomposition of claim 3 which is an oral dissolvable tablet.
 5. Thesublingual dietary supplement composition of claim 1, whereinAshwagandha herb is provided in a range from about 140 mg to about 200mg per dose, and L-theanine is provided in a range from about 160 mg toabout 240 mg per dose.
 6. The sublingual dietary supplement compositionof claim 5, wherein Ashwagandha herb is provided in a range from about150 mg to about 180 mg per dose, and L-theanine is provided in a rangefrom about 180 mg to about 220 mg per dose.
 7. The sublingual dietarysupplement composition of claim 1, wherein Ashwagandha herb andL-theanine are provided in one or more servings.
 8. A nutritionalbeverage comprising Ashwagandha herb and L-theanine in combination witha nutraceutically acceptable carrier.
 9. The nutritional beverage ofclaim 8, wherein Ashwagandha herb is provided in a range from about 140mg to about 200 mg per dose, and L-theanine is provided in a range fromabout 160 mg to about 240 mg per dose.
 10. The nutritional beverage ofclaim 8, wherein Ashwagandha herb and L-theanine are provided in one ormore servings.
 11. The nutritional beverage of claim 8 which is acarbonated beverage.